Non Small Cell Lung Cancer (Squamous or Non Squamous)Phase 2/3TeLuRide-008NCT07365319
A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.
A Phase 2/3 study testing EIK1001, Pembrolizumab (KEYTRUDA®) and Paclitaxel + Carboplatin in people with Non Small Cell Lung Cancer (Squamous or Non Squamous) and Stage 4 NSCLC, run by Eikon Therapeutics at 32 sites in 9 countries.
Trial summary
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (Squamous or Non Squamous), Stage 4 NSCLC
- What is being tested?
- EIK1001, Pembrolizumab (KEYTRUDA®) and Paclitaxel + Carboplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 32 sitesin 9 countries
- Study dates
- 15 Jun 2026to 31 Dec 2040
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 years old at the time of signing the informed consent.
- Participant has a life expectancy of at least 3 months.
- Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
- Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
- Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- Participant has not received prior systemic therapy for advanced/metastatic NSCLC.
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- Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.
- Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
- Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).
Who cannot join
- has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
- is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
- has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
- has received a live-virus vaccination within 30 days of the start of study intervention initiation.
- has received radiation therapy within 7 days of the first dose of study intervention administration.
- has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.
Trial locations and contacts
32 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 9 countries
United States16 sites, 16 recruiting
- Recruiting
University of New Mexico - Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
- Recruiting
Blue Ridge Cancer Center
Blacksburg, Virginia, 24060
- Recruiting
Southern Cancer Center, P.C.
Daphne, Alabama, 36526
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
- Recruiting
Los Angeles Cancer Network
Glendale, California, 91204
- Recruiting
NYU Langone Hospital Long Island
Mineola, New York, 11501
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
NYU Langone Hospital Manhattan
New York, New York, 10016
- Recruiting
Providence St. Joseph Hospital
Orange, California, 92868
- Recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
- Recruiting
Florida Clinical Trials Group
Plantation, Florida, 33322
- Recruiting
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81103
- Recruiting
Florida Clinical Trials Group - Tamarac
Tamarac, Florida, 33321
- Recruiting
Jacobi Medical Center - Albert Einstein College of Medicine
The Bronx, New York, 10461
- Recruiting
White Plains Hospital
White Plains, New York, 10601
- Recruiting
Shenandoah Oncology P.C.
Winchester, Virginia, 22601
Spain5 sites, 5 recruiting
- Recruiting
Instituto Oncologico Dr. Rosell (IOR)
Barcelona, 08028
- Recruiting
Consorci Hospitalari Provincial de Castello
Castellon, Castellón, 12006
- Recruiting
Institut Catala D'Oncologia de Girona
Girona, 17007
- Recruiting
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cadiz, 11407
- Recruiting
Hospital Quirónsalud Málaga
Málaga, 29004
Australia4 sites, 4 recruiting
- Recruiting
Peninsula and Southeast Oncology (PASO) Medical
Frankston, Victoria, 3199
- Recruiting
Cancer Care Northern Beaches
Frenchs Forest, New South Wales, 2086
- Recruiting
Sunshine Hospital - Western Health
Saint Albans, Victoria, 3021
- Recruiting
Calvary Mater Newcastle Hospital
Waratah, New South Wales, 2298
South Korea2 sites, 2 recruiting
- Recruiting
Yeungnam University College of Medicine
Daegu, Daegu, 42415
- Recruiting
Gachon University - Gil Medical Center
Incheon, Incheon Gwang'Yeogsi, 21565
Belgium1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Brugmann
Brussels, 1020
Germany1 site, 1 recruiting
- Recruiting
University Hospital Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Greece1 site, 1 recruiting
- Recruiting
Henry Dunant Hospital Center
Athens, 11516
Poland1 site, 1 recruiting
- Recruiting
GCPMED Sp. z o.o., Centrum Medyczne iMed24
Krakow, Lesser Poland Voivodeship, 31-864
South Africa1 site, 1 recruiting
- Recruiting
Task Eden
George, Western Cape, 6529
About this study
Official title: A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.
Read the detailed description
This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).
- Being tested
- EIK1001, Pembrolizumab (KEYTRUDA®), Placebo, Paclitaxel + Carboplatin, Nab-paclitaxel + Carboplatin
- Keywords
- Non Small Cell Lung Cancer, EIK1001
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIK1001Drug
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Pembrolizumab (KEYTRUDA®)Drug
PD-1 inhibitor
PlaceboDrug
Placebo control
Paclitaxel + CarboplatinDrug
SOC Chemotherapy for squamous NSCLC
Nab-paclitaxel + CarboplatinDrug
SOC Chemotherapy for squamous NSCLC
Pemetrexed + Cisplatin /CarboplatinDrug
SOC Chemotherapy for non-squamous NSCLC
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Placebo in Combination with SOC) | Placebo comparator | Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC). Receives: Drug: Pembrolizumab (KEYTRUDA®); Drug: Placebo; Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin |
| Arm 2 (EIK1001 in Combination with SOC) | Experimental | Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC). Receives: Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA®); Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin |
| Arm 3 (EIK1001 in Combination with SOC) | Experimental | Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC). Receives: Drug: EIK1001; Drug: Pembrolizumab (KEYTRUDA®); Drug: Paclitaxel + Carboplatin; Drug: Nab-paclitaxel + Carboplatin; Drug: Pemetrexed + Cisplatin /Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first
Measured: Through study completion, up to 6 years
Overall survival (OS)
OS defined as the time from the first dose of study medication to death due to any cause
Measured: Through study completion, up to 10 years
Objective Response (OR)
Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).
Measured: Through study completion, up to 6 years
Secondary outcomes (6)
Objective response (OR)
Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR
Measured: Up to 6 years
Duration of response (DOR)
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR.
Measured: Up to 6 years
Progression-free survival (PFS) by Investigator
Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by Investigator, or death due to any cause, whichever occurs first.
Measured: Up to 6 years
Overall Response Rate (ORR) by Investigator
Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator.
Measured: Up to 6 years
Duration of Response (DOR) by Investigator
DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator.
Measured: Up to 6 years
Incidence of Adverse Events (AEs)
Adverse Events (AEs) and discontinuation of study treatment due to any AE.
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Jun 2026
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (Squamous or Non Squamous)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eikon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Nishitha Reddy, Study director, Eikon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365319
- Sponsor's protocol ID
- EIK1001-008
- Other IDs
- 2025-525013-23-00, KEYNOTE-G57, MK-3475-G57, 2025
- Acronym
- TeLuRide-008
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No